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NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities

NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities

Recruiting
18-75 years
All
Phase 2

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Overview

The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for individuals with CKD. The investigators hypothesize that the multilevel NAVIGATE-Kidney program intervention will reduce the rate of central venous catheter use at KRT start (primary outcome), increase the rate of optimal KRT starts (secondary outcome), increase patient activation, and reduce decisional conflict (patient-centered outcomes) for individuals with advanced CKD. The project will have four (4) aims.

Description

The overarching goal of this project is to reduce kidney health disparities faced by individuals with advanced kidney disease. The team developed Navigate-Kidney, a community health worker (CHW) intervention to improve clinical and person-centered outcomes for individuals with kidney failure receiving maintenance hemodialysis. The investigators now aim to test NAVIGATE-Kidney among individuals with advanced CKD stage 4. The investigators hypothesize that compared to standard care, the multilevel NAVIGATE-Kidney intervention will reduce the composite endpoint, defined as (1) time to transition to KRT and central venous catheter use or (2) death (primary outcome), increase the rate of optimal KRT starts and optimal KRT process measures (secondary clinical outcomes), increase patient activation, reduce social challenges, and reduce decisional conflict (patient-centered outcomes) for individuals with advanced CKD stage 4/5 (eGFR 15-29 mL/min/1.73m2). The investigators will also evaluate Navigate-Kidney implementation outcomes using the PRISM (Practical Robust Implementation and Sustainable Model) science framework and conduct an economic evaluation to inform policy change.

Eligibility

Inclusion Criteria:

  • Adults ≥ 18 years of age,
  • Adults who are not pregnant,
  • Adults who are not incarcerated,
  • Adults who have advanced kidney disease with an eGFR of 15-29 mL/min/1.73m2). No other measures are used to identify eligible patients.

Exclusion Criteria:

  • Previous kidney transplant
  • Previous surgery for dialysis such as an arteriovenous fistula, arteriovenous graft, or peritoneal dialysis catheter placement
  • On chronic dialysis
  • Conservative management or primary goal is palliation
  • Incarcerated
  • Pregnant\
  • Under 18 years of age
  • Moderate to severe dementia
  • Deaf persons
  • Lacking health insurance\\*
  • Investigator Discretion: Individuals who, in the judgment of the Site PI (or designee), are deemed unsuitable for participation due to behavioral or logistical circumstances that could compromise study integrity or the safety of the participant or staff.

Study details
    Kidney Diseases
    Chronic Kidney Diseases

NCT06810622

University of Colorado, Denver

13 May 2026

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